NCT01445717

Brief Summary

This study evaluates the use of a new method of growing and detecting Group B streptococcus in pregnant women. This new method utilizes sandwiched-membrane petri technology and has the advantage of detecting GBS in less than 6 hours, with less cost, and the potential of allowing antibiotic sensitivities to be performed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
358

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

May 3, 2013

Status Verified

May 1, 2013

Enrollment Period

2 years

First QC Date

September 30, 2011

Last Update Submit

May 2, 2013

Conditions

Streptococcus InfectionPregnancy

Keywords

GBS, Streptococcus, .Group B

Outcome Measures

Primary Outcomes (1)

  • Culture of Group B streptococcus

    Rapid assay results will be compared to routine culture results.

    48 hours

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant patients who present to the UT resident or attending clinic between 35-37 weeks for routine follow-up will be asked to enroll.

You may qualify if:

  • \> 18 years
  • weeks pregnancy
  • Patient receiving prenatal care at UT Houston Hermann Memorial OB/Gyn resident or attending clinic.

You may not qualify if:

  • Pt elects not to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UTHSC at Houston

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Specimens are to be retained for one month, frozen in LIM broth, and will be held for use if reprocessing specimens is required.

MeSH Terms

Conditions

Streptococcal InfectionsGuillain-Barre Syndrome

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jonathan Faro, MD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, ObGyn

Study Record Dates

First Submitted

September 30, 2011

First Posted

October 4, 2011

Study Start

November 1, 2010

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

May 3, 2013

Record last verified: 2013-05

Locations

US(1)